antibody persistence for glaxosmithkline (gsk) biologicals' hpv-16/18 l1 vlp as04 vaccine (gsk-580299) administered in healthy adults and adolescents, 6.5 years after first vaccination in the primary study

Conditions: Infections, Papillomavirus

Summary: the purpose of this study is to establish the long-term persistence of the immune response and safety of the hpv vaccine in healthy females who were aged 9 to 25 years in the primary study (nct00541970).


Eligibility criteria:
inclusion criteria: * subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or subjects' parent(s)/legally acceptable representative(s) \[lar(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * subjects who completed their primary vaccination and received either two or three doses of gsk biologicals' hpv-16/18 vaccine according to a 0,6-months schedule or a 0,1,6-months schedule in the study hpv-048 pri (110659) (nct00541970). * a female between, and including, 9 and 14 years of age or 15 and 25 years of age, at the time of first vaccination, depending on which group they belonged to in the study hpv-048 pri (110659) (nct00541970), i.e., 9-14 year old subjects should have received two doses of gsk biologicals' hpv-16/18 vaccine according to a 0,6-months schedule and 15-25 year old subjects should have received three doses of gsk biologicals' hpv-16/18 vaccine according to a 0,1,6-months schedule. * written informed consent obtained from the subject/from the parent(s)/lar(s) of the subject. in addition, subjects below the legal age of consent should sign and personally date a written informed assent form. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * child in care. * use of any investigational or non-registered product (drug or vaccine) other than the hpv-16/18 study vaccine administered in the study hpv-048 pri (110659) (nct00541970) from the last visit of the primary study up to the current study visit or planned use during the study period. * administration of any hpv vaccine from the last visit of the primary study up to the current study visit or planned use during the study period. * chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within three months prior to blood sampling. inhaled and topical steroids are allowed. * planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before study entry, with the exception of routine meningococcal, inactivated influenza, hepatitis b, diphtheria/tetanus and/or diphtheria/tetanus-containing, poliomyelitis and/or pertussis vaccines up to 8 days before study entry. enrolment will be deferred until the subject is outside of specified window. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * cancer or autoimmune disease under treatment. * administration of immunoglobulins and/or any blood products within the 3 months preceding the blood sampling.

Keywords: adolescents adults immunogenicity 6.5 years safety antibody persistence human papillomavirus (hpv) vaccine